(230 days)
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
The provided text describes a 510(k) summary for the Bonutti Research, Inc. Unity Ultrasonic System. It details changes made to the system and compares it to predicate devices. However, the document does not provide specific acceptance criteria or the details of a study that proves the device meets such criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond general "mechanical strength testing").
Therefore, I cannot populate the requested table or answer most of the questions fully as the information is not present in the provided text.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (beyond "electrical output compared" and "mechanical strength testing conducted") |
Explanation: The document states that "Design verification testing identified and conducted as part of the predicate comparison... compared the electrical output of the modified Unity Ultrasonic System electrical generator and ultrasonic handpiece to similar component predicate devices. Mechanical strength testing was also conducted with Unity Alpha predicate devices: for both the modified Unity Ultrasonic System and its predicate ultrasonic systems." However, it does not provide the specific numerical acceptance criteria (e.g., "electrical output must be within X% of predicate") nor the actual measured performance values.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described as "Design verification testing" and "mechanical strength testing," implying laboratory or bench testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes design verification and mechanical strength testing, not studies requiring expert-established ground truth for performance metrics like those for diagnostic AI systems.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a "Fixation Device" (Unity Ultrasonic System) for surgical use, not a diagnostic imaging or AI-assisted interpretation tool. The testing described is related to the device's mechanical and electrical properties.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a surgical fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "mechanical strength testing" and "electrical output comparison," the ground truth would inherently be engineering specifications, physical measurements, and the performance characteristics of the predicate devices. It is not an expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The sample size for the training set:
- Not applicable. The document describes device modifications and comparative testing, not the development of a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through design verification and mechanical testing, specifically for an ultrasonic surgical fixation system. It does not contain the detailed performance metrics, study designs, or ground truth establishment methods typically associated with AI/ML-driven diagnostic devices or clinical comparative effectiveness studies.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.